Comparing telehealth and web-based cognitive behavioral therapy for insomnia in people with multiple sclerosis
Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
This study is testing whether online therapy for insomnia delivered through video calls works better than web-based therapy or standard treatment to help people with multiple sclerosis sleep better and feel less tired.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06434571 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of telehealth-delivered cognitive behavioral therapy for insomnia (tCBT-I) versus web-based cognitive behavioral therapy for insomnia (wCBT-I) and standard treatment to improve sleep quality, reduce fatigue, and enhance quality of life in individuals with multiple sclerosis. Participants will undergo a 6-week intervention, followed by assessments at 6 months to measure outcomes related to sleep, fatigue, and neuroprotection. The study also seeks to identify participant characteristics that may predict improvements in sleep outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of relapsing-remitting or secondary progressive multiple sclerosis and insomnia symptoms.
Not a fit: Patients with untreated sleep disorders such as sleep apnea or restless legs syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sleep quality and overall well-being for patients with multiple sclerosis experiencing insomnia.
How similar studies have performed: Previous studies have shown promising results for cognitive behavioral therapy in treating insomnia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-65 years old * Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 and verified by their neurologist * Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale) * Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5 * ≥10 on Insomnia Severity Index * English speaking * ≥31 on Telephone Interview of Cognitive Status * Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study * Report having access to internet service or a data plan and access to a computer, tablet, or smart phone Exclusion Criteria: * Known untreated sleep disorder (such as sleep apnea or restless legs syndrome) * \>3 on STOP BANG indicating increased risk of sleep apnea * Restless legs syndrome as determined by RLS-Diagnosis Index * Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised * Parasomnia as determined by the Sleep Disorders-Revised * If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months * Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9) * Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety * Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria * History of other nervous system disorder such as stroke or Parkinson's disease * Currently pregnant or intending to become pregnant in the next 6 months * Severe mental illness such as schizophrenia or bipolar disorder * Severe neurological or sensory impairments that would interfere significantly with testing * Relapse and/or corticosteroid use in the past 8 weeks * History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am * Currently receiving a behavioral sleep health intervention
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center- Sleep, Health and Wellness Laboratory — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Eryen Nelson, MPH
- Email: enelson5@kumc.edu
- Phone: 913-945-7349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.